ENTYVIO® (Vedolizumab)

ENTYVIO®

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Important Safety Information

ENTYVIO® (vedolizumab) could affect other medications you are currently taking. Prior to starting treatment, tell your doctor about all medications — whether prescription, over-the-counter, or herbal. Also, tell your doctor if you have an infection or think you have an infection, have tuberculosis (TB) or have been in close contact with someone who has TB, have recently been vaccinated or have a vaccine scheduled, or if you’re pregnant, breastfeeding, or plan to become pregnant or breastfeed.

What is the most important information I should know about ENTYVIO®?

ENTYVIO® is not recommended for individuals with an active or severe infection until the infection is controlled. ENTYVIO® should only be administered by an experienced healthcare professional who can manage allergic reactions — including anaphylaxis.

ENTYVIO® Side Effects

Side effects of ENTYVIO® could occur either during treatment or several hours after the infusion. Let your doctor know immediately if you’re experiencing symptoms of an allergic reaction, including:

  • Itching
  • Swelling of your lips, tongue, or face
  • Rash
  • Shortness of breath
  • Fast heartbeat
  • Hot flashes
  • Dizziness

Common Cold

One of the most common side effects of ENTYVIO® includes developing the common cold — along with typical symptoms of the conditions, such as tiredness, cough, and a sore throat. Symptoms could also be exacerbated and include fever, chills, nausea, nose and throat infection, joint pain, back pain, bronchitis, and influenza.

Multifocal Leukoencephalopathy (PML)

PML is a rare brain infection. Individuals with a weakened immune system are susceptible to developing the condition — which could result in severe disability or death. Tell your medical provider immediately if you experience loss of balance, a change in gait, weakness on one side of your body, blurred vision, trouble concentrating, and/or confusion.

Liver Problems

Tell your doctor if you experience any symptoms of liver problems, including yellowing of the skin and whites of the eyes, tiredness, pain on the right side of the abdomen, dark urine, and/or loss of appetite. These may be signs that your liver is failing.

Tell your doctor if you experience any negative side effects. You are also encouraged to report such side effects to the Food and Drug Administration (FDA) by visiting www.fda.gov/medwatch, or by calling 1-800-FDA-1088.

Indications

ENTYVIO® is a prescription infusion medication used to treat adults with moderate to severe ulcerative colitis and moderate to severe Crohn’s disease when traditional medications have not yielded results or cannot be tolerated by the patient. Infusions should be administered for approximately 30 minutes. Repeat treatments at two and six weeks — then every eight weeks thereafter. Each infusion treatment should be monitored through its duration.

ENTYVIO® Prescribing Information

Please refer to ENTYVIO’s full Prescribing Information.